Enfortumab vedotin (Padcev®). HTA ID: 22024

Assessment Status NCPE Assessment Process Complete
HTA ID 22024
Drug Enfortumab vedotin
Brand Padcev®
Indication As monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor
Assessment Process
Rapid review commissioned 22/04/2022
Rapid review completed 18/05/2022
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of enfortumab vedotin (Padcev®) compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 27/05/2022
Pre-submission consultation with Applicant 19/07/2022
Full submission received from Applicant 23/11/2022
Preliminary review sent to Applicant 16/03/2023
NCPE assessment re-commenced 17/04/2023
Factual accuracy sent to Applicant 21/06/2023
NCPE assessment re-commenced 28/06/2023
NCPE assessment completed 12/07/2023
NCPE assessment outcome The NCPE recommends that enfortumab vedotin (Padcev®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE has approved reimbursement following confidential price negotiations December 2023.